Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

— IMCXvsCIMT  

Official title:

Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212549
• Other study ID #: 524270910
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2010
• Last updated: August 31, 2011
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2011
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)

Description:

Comparison of efficacy

• Number of patients: N=40

• Arms: Two equal arms (20 patients each)

• Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy

• Exclusion criteria: (1) Size of the tumors >5cm; (2) Distance from the eyelid <0,5cm; (3)Number of tumors >5

• Interim analysis: When at least 10 patients are included in each arm or at the end of the first year of the study

The patients will be randomized in 2 groups Group 1 (Immunocryosurgery) and Group 2 (Cryoimmunotherapy)

Treatment protocols:

Group 1 (Immunocryosurgery): Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again.

Group 2 (Cryoimmunotherapy): Patients will be submitted into cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) and subsequently will apply imiquimod on the tumor and a rim of 2mm around the tumor for 5 weeks in total. They will be evaluated in week 2 and 5.

Patients from both groups will be evaluated at 1, 3, 6, 12 months after termination of imiquimod treatment. In case of clinical relapse, it will be confirmed by biopsy and all the patients will treated with immunocrysurgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Biopsy proven basal cell carcinoma of the skin

• Size <5cm

• Number of tumors <5 cm

• Distance from eyelids, mouth 0,5cm

Exclusion Criteria:

• Size >5cm

• Number of tumors > or =5

• Distance from eyelids or mouth < or =0.5cm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Procedure:
• Immunocryosurgery
2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod
• Cryoimmunotherapy
Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod

Locations

Country	Name	City	State
Greece	Department for Skin and Venereal Diseases, University Hospital	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Bassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. doi: 10.1016/j.cryobiol.2009.04.011. Epub 2009 May 6. — View Citation

Bassukas ID, Gamvroulia C, Zioga A, Nomikos K, Fotika C. Cryosurgery during topical imiquimod: a successful combination modality for lentigo maligna. Int J Dermatol. 2008 May;47(5):519-21. doi: 10.1111/j.1365-4632.2008.03562.x. — View Citation

Gaitanis G, Mitsou G, Tsiouri G, Alexis I, Bassukas ID. Cryosurgery during imiquimod cream treatment ("immunocryosurgery") for Bowen's disease of the skin: a case series. Acta Derm Venereol. 2010 Sep;90(5):533-4. doi: 10.2340/00015555-0896. — View Citation

Gaitanis G, Nomikos K, Vava E, Alexopoulos EC, Bassukas ID. Immunocryosurgery for basal cell carcinoma: results of a pilot, prospective, open-label study of cryosurgery during continued imiquimod application. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1427-31. doi: 10.1111/j.1468-3083.2009.03224.x. Epub 2009 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy		1 month	No